Express 2 Monorail Coronary Stent Systems (bare metal stents) - balloon expandable Express 316L stainless steel Stent pr
FDA device recall Z-1121-04 · posted 2004-07-27 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure.
- Action taken
- Press release has been issued. Institutions with affected units will receive packages outlining the recall process and should immediately discontinue use of these units. Clinician and patient inquiries may be directed to Boston Scientific.
- Root cause
- Other
- Status
- Terminated
- Product code
- MAF
- Quantity affected
- 82,424
- Distribution
- Inside U.S.
- Date initiated
- 2004-07-16
- Date posted
- 2004-07-27
- Date terminated
- 2005-11-29
- Location
- Natick, MA
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