Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported January 25, 2017
Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheathand introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use inperipheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in cerebrovascular nor the coronary vasculature
Complaints of sheath separation, kinking, and/or tip damage during use.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bard Peripheral Vascular, INC recalled Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guidi… - a critical-severity action.
Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guidi… was recalled by Bard Peripheral Vascular, INC in January 25, 2017. Reason: Complaints of sheath separation, kinking, and/or tip damage during use.. Check the official notice for the remedy. Verify recall #Z-0968-2017 with the FDA Devices before acting.
The recall
Bard Peripheral Vascular, INC issued this critical-severity FDA Devices recall-Complaints of sheath separation, kinking, and/or tip damage during use..
- Critical
- severity level
- 101 units
- affected scope
- Class I
- classification
- January 25, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0968-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0968-2017) was formally reported on January 25, 2017, with the manufacturer initiating the action on December 2, 2016. It is classified under Critical severity (Class I), with a current status of Terminated. Bard Peripheral Vascular, INC is listed as the recalling firm, operating out of Tempe, AZ. Federal records list the affected scope as 101 units.
The documented reason for this recall is: Complaints of sheath separation, kinking, and/or tip damage during use. Distribution data in the federal record shows the product reached: Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
101 units
Related Recalls
6
3 from same agency
Product description
Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheathand introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use inperipheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in cerebrovascular nor the coronary vasculature
Reason for recall
Complaints of sheath separation, kinking, and/or tip damage during use.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0968-2017 |
| Date reported | January 25, 2017 |
| Date initiated | December 2, 2016 |
| Recalling firm | Bard Peripheral Vascular, INC |
| Firm location | Tempe, AZ |
| Affected scope | 101 units |
| Distribution | Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution. |
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-0968-2017) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheathand introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use inperipheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in cerebrovascular nor the coronary vasculature. Recalled by Bard Peripheral Vascular, INC. Units affected: 101 units.
Why was this product recalled? ▼
Complaints of sheath separation, kinking, and/or tip damage during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 25, 2017. Severity: Critical. Recall number: Z-0968-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0968-2017) 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 January 25, 2017. 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.