Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This cat
FDA device recall Z-0900-2014 · posted 2014-01-30 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter.
- Action taken
- Boston Scientific sent an Urgent Medical Device Recall Removal letter dated January 14, 2014 to all affected customers by overnight mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete an Account Reply verification Tracking Form in order to received a Return Goods Authorization number for product return. For questions contact your local Sales Representative.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 1068 single units
- Distribution
- US Nationwide Distribution and Mexico
- Date initiated
- 2014-01-06
- Date posted
- 2014-01-30
- Date terminated
- 2014-10-29
- Location
- Fremont, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATLANTIS PVIMAGING CATHETER, MODEL H749364560 (K080272) | Boston Scientific Corp | 2008-03-11 |