Z-1999-2014Class II

07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative...

Name: Z-1999-2014 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative...
Creator: Vascular Technology, Inc.
Published: 2014-05-28
License: https://open.fda.gov/license/

Vascular Technology Incorporated / initiated 2014-05-28 / Terminated / root cause: manufacturing process

FDA source

Vascular Technology, Inc. began a recall of 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 on 2014-05-28. FDA classified it as Class II and gives the reason as "Report of the product penetrating the sterile barrier; this could render the product unsterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1999-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-28
Posted: 2014-07-07
Terminated: 2016-02-11
Recalling firm: Vascular Technology Incorporated
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.
Product code: DPW Flowmeter, Blood, Cardiovascular
Reason for recall: Report of the product penetrating the sterile barrier; this could render the product unsterile.
Root cause tag: manufacturing process
FDA 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 in commerce: 147
Distribution: Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.
Product codes and lots: LOT NUMBER 11802-37667

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1999-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1998-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07
Z-1999-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07
Z-2000-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07
Z-2001-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07

Product code DPW

K082870Class IIVti Intraoperative Doppler SystemsVascular Technology Incorporated / cleared 2008-10-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)