07-150-10 Mizuho, Doppler Probe, Slim, Bx 4, Ref 138660 recallZ-1999-2014 · Vascular Technology, Inc. · initiated May 28, 2014
Class II Terminated All recalls posted in July 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Vascular Technology, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Report of the product penetrating the sterile barrier; this could render the product unsterile.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-1999-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 28, 2014
- Posted by the FDA
- Jul 7, 2014
- Recalling firm
- Vascular Technology, Inc.
- Quantity
- 147
- Product code
- DPW
- FDA submissions
- K082870
- Distribution
- Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.
Product description
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.
Code information (models, lots, serial numbers)
LOT NUMBER 11802-37667
Other devices under the same FDA submission
1 device cleared under K082870 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Mizuho 07-150-10 Disposable Doppler Probe for Neurosurgery, Box 138660Vascular Technology, Incorporated · FLOWMETER, BLOOD, CARDIOVASCULAR1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 68512).
- Z-1998-2014 · Terminated07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
- Z-2000-2014 · Terminated07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
- Z-2001-2014 · TerminatedVTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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