Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011
FDA device recall Z-0729-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Boston Scientific Scimed
- Reason for recall
- 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 damage to organs other than the brain.
- Action taken
- Consignees were sent a recall letter dated February 13, 2004. The letter requested that consignees discontinue use of the recalled catheters and return them.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 11 catheters
- Distribution
- The product was shipped to consignees in Florida in the United States.
- Date initiated
- 2004-02-13
- Date posted
- 2004-07-20
- Date terminated
- 2006-12-28
- Location
- Maple Grove, MN
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