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Terminated

Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-7020

FDA Recall Z-1112-03 · Posted 2003-08-12

Recalling FirmBoston Scientific Scimed
Recall StatusTerminated
Product CodeGBR
Date Initiated2003-07-01
Date Terminated2006-12-28
Product Quantity17

Reason for Recall

Some of the product pouches have holes in the seals.

Firm Action

Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.

Root Cause

Other

Distribution Pattern

The recalled products were shipped to hospitals located nationwide in the United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021735BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETERBoston Scientific Scimed, Inc. · 2002-08-08

Official Source

View FDA Recall →

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

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