FDA · Medical device recall

Ultra-soft SV Monorail Balloon Dilatation Catheters… and 24 more products

Aug. 12, 2003

Date posted by the FDA: Aug. 12, 2003
Status: Terminated
Filed by: Boston Scientific Scimed
Reason: Some of the product pouches have holes in the seals.
Distribution pattern: The recalled products were shipped to hospitals located nationwide in the United States.

25 products in this recall

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm / 1.5 cm /90 cm (balloon width/balloon length/catheter length), Reference Catalog Number 37915-4015
Quantity: 42
Codes and lots: Lot numbers 5490976, 5530109, and 5564475
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1096-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalog Number 37915-4020
Quantity: 85
Codes and lots: Lot numbers 5462665, 5486700, 5509423, 5570097, 5580887, 5591636, and 5592100
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1097-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-4515
Quantity: 3
Codes and lots: Lot number 5491423
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1098-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-5020
Quantity: 114
Codes and lots: Lot numbers 5458926, 5459705, 5462880, 5464053, 5523106, 5570556, 5576584, and 5581120
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1099-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-6015
Quantity: 16
Codes and lots: Lot numbers 5486922 and 5625627
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1100-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.5 mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-6520
Quantity: 8
Codes and lots: Lot number 5138299
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1101-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-7015
Quantity: 25
Codes and lots: Lot numbers 5491707 and 5563990
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1102-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-7020
Quantity: 70
Codes and lots: Lot numbers 5487644, 5514945, 5524567, 5531394, 5560048, 5571045, and 5581781
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1103-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-4015
Quantity: 13
Codes and lots: Lot number 5493302
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1104-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-4020
Quantity: 78
Codes and lots: Lot numbers 5463361, 5463825, 5467755, 5591116, and 5592367
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1105-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-4515
Quantity: 6
Codes and lots: Lot number 5523632
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1106-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-4520
Quantity: 12
Codes and lots: Lot numbers 5470240 and 5493444
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1107-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-5015
Quantity: 14
Codes and lots: Lot number 5464221
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1108-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.5 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-5520
Quantity: 14
Codes and lots: Lot number 5463435
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1109-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-6015
Quantity: 6
Codes and lots: Lot number 5515405
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1110-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.5 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-6515
Quantity: 4
Codes and lots: Lot number 5493691
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1111-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-7020
Quantity: 17
Codes and lots: Lot numbers 5463705 and 5464511
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1112-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/150 cm, Reference Catalog Number 38950-5020
Quantity: 5
Codes and lots: Lot number 5554279
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1113-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/2.0 cm/150 cm, Reference Catalog Number 38950-6020
Quantity: 58
Codes and lots: Lot numbers 5470562, 5536519, 5543449, and 5554623
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1114-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/1.5 cm/90 cm, Reference Catalog Number 38990-4015 , Product Number H7493791540150
Quantity: 3
Codes and lots: Lot number 5562834
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1115-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-4020
Quantity: 22
Codes and lots: Lot numbers 5531084 and 5543317
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1116-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/1.5 cm/90 cm, Reference Catalog Number 38990-5015
Quantity: 17
Codes and lots: Lot number 5455553
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1117-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-5020
Quantity: 48
Codes and lots: Lot numbers 5519448, 5519891, 5537795, and 5551411
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1118-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-6020
Quantity: 62
Codes and lots: Lot numbers 5455345, 5536214, 5551137, 5563785, and 5620006
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1119-03

Ultra-soft SV Monorail Balloon Dilatation Catheters…

Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-7020
Quantity: 22
Codes and lots: Lot numbers 5490680, 5540265, and 5584469
Recall started: July 1, 2003
Root cause (FDA): Other
What the company told customers: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Recall number: Z-1120-03

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1096-03, Z-1097-03, Z-1098-03, Z-1099-03, Z-1100-03, Z-1101-03, Z-1102-03, Z-1103-03 and others. The agency record governs; check it and the company before acting.

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