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Terminated

Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011

FDA Recall Z-0729-04 · Posted 2004-07-20

Recalling FirmBoston Scientific Scimed
Recall StatusTerminated
Product CodeDQO
Date Initiated2004-02-13
Date Terminated2006-12-28
Product Quantity11 catheters

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.

Firm Action

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

Distribution Pattern

The product was shipped to consignees in Florida in the United States.

Official Source

View FDA Recall →

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

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