Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111,
FDA device recall Z-0588-2016 · posted 2016-01-05 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Potential for separation of the proximal handle from the shaft.
- Action taken
- Boston Scientific personnel began retrieving product from hospital shelves on November 25, 2015. The hospital was given a Medical Device Retrieval letter. The letter provided the reason for product retrieval, identified affected product, asked for product to be segregated to ensure that it will not be used, and to contact Boston Scientific for a return authorization number to ship product back to Boston Scientific. A Certificate of Removal was asked to be completed and emailed to BSCFieldActionCenter@bsci.com Questions can be addressed to Technical Services at 1-800-227-3422.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 900 units
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Colombia, Cyprus, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Hong K
- Date initiated
- 2015-11-25
- Date posted
- 2016-01-05
- Date terminated
- 2016-04-08
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUITY PRO LEAD DELIVERY SYSTEM (K132914) | Boston Scientific | 2014-04-03 |