FDA Medical Device Recalls (openFDA)
Boston Scientific Scimed: Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-4020
- Recall number
- Z-1116-03
- Recalling firm
- Boston Scientific Scimed
- Product
- Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-4020
- Status
- Terminated
- Initiated
- 2003-07-01
- Posted
- 2003-08-12
- Terminated
- 2006-12-28
- Reason
- Some of the product pouches have holes in the seals.
- Root cause
- Other
- 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.
- Quantity
- 22
- Distribution
- The recalled products were shipped to hospitals located nationwide in the United States.
- Lot, serial or model codes
- Lot numbers 5531084 and 5543317
- 510(k) numbers
- ["K021735"]
- PMA numbers
- not on file
- Product code
- GBR
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28