Z-3026-2018Class II

VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular...

Name: Z-3026-2018 VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular...
Creator: Vascular Technology, Inc.
Published: 2018-06-19
License: https://open.fda.gov/license/

Vascular Technology Incorporated / initiated 2018-06-19 / Terminated / root cause: labeling and UDI

FDA source

Vascular Technology, Inc. began a recall of VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological... on 2018-06-19. FDA classified it as Class II and gives the reason as "Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3026-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-19
Posted: 2018-09-12
Terminated: 2020-01-30
Recalling firm: Vascular Technology Incorporated
Product: VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.
Product code: DPW Flowmeter, Blood, Cardiovascular
Reason for recall: Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: The firm, Vascular Technology, Inc., "URGENT: MEDICAL RECALL DEVICE" letter dated June 18, 2018, to its customer on June 19, 2018. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine inventory and return all product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. If you have any questions, contact VP Sales person at 603-594-9700.
Quantity in commerce: 10 units
Distribution: US Distribution to state of: CA.
Product codes and lots: Serial Numbers: 14329-001, 14329-002, 14329-003, 14329-004, 14329-005, 14329-006, 14329-007, 14329-008, 14329-009, and 14329-010.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3026-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3026-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-12

Product code DPW

K031091Class IIVti 20 Mhz Gated DopplerVascular Technology Incorporated / cleared 2003-04-23

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)