Device recall: 07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and trans
FDA enforcement event 68512 is a device recall by Vascular Technology, Inc. of Nashua, NH, initiated 28 May 2014 and classified Class II, with 4 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 11 Feb 2016. Initiation: voluntary: firm initiated. Vascular Technology, Inc. has 2 enforcement events on this register, with a median of 4 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Vascular Technology, Inc., Nashua, NH.
Reason for recall
"Report of the product penetrating the sterile barrier; this could render the product unsterile."
Distribution
"Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1998-2014 | 07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow. | 164 | Class II | Terminated | 16 Jul 2014 |
| Z-1999-2014 | 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. | 147 | Class II | Terminated | 16 Jul 2014 |
| Z-2000-2014 | 07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow. | 34 | Class II | Terminated | 16 Jul 2014 |
| Z-2001-2014 | VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow. | 25 | Class II | Terminated | 16 Jul 2014 |
Context
Other enforcement events for Vascular Technology, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Jun 2018 | VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascul (80527) | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Report of the product penetrating the sterile barrier; this could render the product unsterile."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Feb 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.