PlainRecordsBrand recall history
Boston Scientific Scimed recalls
Every FDA recall record we found for Boston Scientific Scimed, newest first. Updated Oct. 11, 2026.
14
14 recalls since 2003. The most recent was on Jan. 25, 2006.
- Last 12 months
- 0
- Most recent
- 2006-01
- Most serious (FDA Class I)
- 0
- Last 30 days
- 0
Recalls by year
2012–2026121314151617181920212223242526
Class I (FDA, most serious)Other recalls
All recalls
14- Jan. 25, 2006Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System… One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. The…
- Jan. 24, 2006Mach 1 6F Kimny Guide Catheter… and 1 more product Some Mach 1 6F Coronary Guide Catheter could be mislabeled in that a few units labeled as Mach 1 6F Kimny Curve style, could contain a Mach 1 6F JR…
- Dec. 23, 2005Stainless Steel Greenfield Vena Cava Filter with 12 Fr… and 1 more product Certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of…
- June 25, 2005PTFE (Polytetrafluoroethylene) felt… Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength.
- Jan. 28, 2005RunWay 6F Cardiovascular Guide Catheter The Runway guide catheter do not meet internal product specifications. Specifically, the affected catheters have exposed or protruding braid wires in…
- Aug. 13, 2004WALLSTENT Endoprostheses with UNISTEP Plus Delivery System Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use.
- July 20, 2004TAXUS Express Paclitaxel-Eluting MONORAIL Coronary Stent System (3.5 x 32mm)… On a few occasions the balloon has failed to deflate within one minute after deployment of the stent.
- July 20, 2004Impulse 5F 145 (degree) Multipack Angiographic Catheters… Some of the catheters may have yellow foreign material in their pigtail tips. The foreign material in the device could cause a stroke or significant…
- Oct. 15, 2003Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation… and 2 more products Some of the recalled catheters have a component that has levels of pyrogens above specification.
- Aug. 29, 2003Boston Scientific Medi-Tech Imager II 5F Selective Angiographic Catheter Some of the recalled catheters may be in pouches with incomplete seals.
- Aug. 12, 2003Boston Scientific Scimed Monorail Express 2 Coronary Stent System… There is an Increased potential for broken struts of the stents.
- Aug. 12, 2003Ultra-soft SV Monorail Balloon Dilatation Catheters… and 24 more products Some of the product pouches have holes in the seals.
- April 22, 2003Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm Stent Systems… and 2 more products A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.
- April 9, 2003Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System… The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility.
No recalls match.
How we match: a recall is listed here when the agency names Boston Scientific Scimed as the company that filed it. Sources: FDA enforcement reports and FDA-posted company announcements, CPSC recall notices and NHTSA recall campaigns.