Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 6, 2014
FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Baxter Healthcare.
Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and p…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Baxter Healthcare Corporation recalled FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used … - a moderate-severity action.
FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used … was recalled by Baxter Healthcare Corporation in August 6, 2014. Reason: Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not …. Check the official notice for the remedy. Verify recall #Z-2126-2014 with the FDA Devices before acting.
The recall
Baxter Healthcare Corporation issued this moderate-severity FDA Devices recall-Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not ….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- August 6, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2126-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2126-2014) was formally reported on August 6, 2014, with the manufacturer initiating the action on July 11, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Baxter Healthcare Corporation is listed as the recalling firm, operating out of Westlake Village, CA. Federal records list the affected scope as 1,315 units.
The documented reason for this recall is: Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of … Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and the countries of United Kingdom, Germany, Sweden, Spain, Israel and Denmark.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,315 units
Related Recalls
6
3 from same agency
Product description
FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Baxter Healthcare.
Reason for recall
Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of Doppler signal. This may result in the inability to monitor anastomotic patency, with the possibility that blood flow may not be appropriately monitored.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2126-2014 |
| Date reported | August 6, 2014 |
| Date initiated | July 11, 2014 |
| Recalling firm | Baxter Healthcare Corporation |
| Firm location | Westlake Village, CA |
| Affected scope | 1,315 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of United Kingdom, Germany, Sweden, Spain, Israel and Denmark. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2126-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Baxter Healthcare.. Recalled by Baxter Healthcare Corporation. Units affected: 1,315 units.
Why was this product recalled? ▼
Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of Doppler signal. This may result in the inability to monitor anastomotic patency, with the possibility that blood flow may not be appropriately monitored.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 6, 2014. Severity: Moderate. Recall number: Z-2126-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and the countries of United Kingdom, Germany, Sweden, Spain, Israel and Denmark..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2126-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 6, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.