FDA Medical Device Recalls (openFDA)
Vascular Technology, Inc.: 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
- Recall number
- Z-1999-2014
- Recalling firm
- Vascular Technology, Inc.
- Product
- 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
- Status
- Terminated
- Initiated
- 2014-05-28
- Posted
- 2014-07-07
- Terminated
- 2016-02-11
- Reason
- Report of the product penetrating the sterile barrier; this could render the product unsterile.
- Root cause
- Process design
- Action
- Vascular Technology sent an Urgent Medical Device Recall letter dated May 28, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This recall has been initiated due to a report of the product penetrating the sterile barrier; this could render the product unsterile. Use of this product may lead to infection in the patient. Please immediately examine your inventory and return all product subject to recall to Vascular Technology at the above mentioned address. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customer must include instructions telling your customer to return the recalled product if unused or to account for the recalled product if it has been used. For further questions please call (603) 594-9700.
- Quantity
- 147
- Distribution
- Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.
- Lot, serial or model codes
- LOT NUMBER 11802-37667
- 510(k) numbers
- ["K082870"]
- PMA numbers
- not on file
- Product code
- DPW
- Firm FEI
- 1221072
- Firm city
- Nashua
- Firm state
- NH
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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