Terminated

Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. 1) 4.00mm x 15mm Small Peripheral Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #001BPM4015140F0, Catalogue # BPM4015140F & UPN # M001PCBM4015140F0, Catalogue # PCBM4015140F. 2) 4.00mm x 15mm Small Peripheral Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # M001PCBO4015140F0, Catalogue # PCBO4015140F.

FDA Recall Z-2137-2013 · Posted 2013-09-03

Recalling FirmBoston Scientific Corporation

Recall StatusTerminated

Product CodeLIT

Date Initiated2013-07-31

Date Terminated2015-01-27

Product Quantity1,331

Reason for Recall

Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the devic

Firm Action

Boston Scientific sent an Urgent Medical Device Recall Removal letter dated July 30, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised that further distribution or use of the product should cease immediately, and to segregate the product and return it to Boston Scientific. Consignees were asked to complete and return the "Recall Removal Reply Verification Tracking Form". For questions consignees were instructed to contact their local Sales Representative. For questions regarding this recall call 763-494-2042.

Root Cause

Process change control

Distribution Pattern

Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV,NH,NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC,SC, TN, TX, UT, VA, WA, WV, and WI. Internationally to Algeria, Finland, Japan, Spain, Australia, France, Latvia, Sweden, Austria, Germany, Netherlands, Switzerland, Belgium, Great Britain, Norway, Taiwan, Brazil, Greece, Panama, Turkey, Canada, Hong Kong, Poland, Unit.Arab Emir., China, India, Russian Fed., Colombia, Ireland, Saudi Arabia, Czech Republic, Israel, South Africa, Denmark, Italy, and South Korea.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.