Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported November 18, 2015
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation designed for plaque modification and debulking in vascular interventions. This system is designed to travel over a specialized 0.009 guidewire to guide the path of burr travel to deliver therapy where intended.
Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Ro…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Boston Scientific Corporation recalled RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra S… - a critical-severity action.
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra S… was recalled by Boston Scientific Corporation in November 18, 2015. Reason: Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire …. Check the official notice for the remedy. Verify recall #Z-0212-2016 with the FDA Devices before acting.
The recall
Boston Scientific Corporation issued this critical-severity FDA Devices recall-Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire ….
- Critical
- severity level
- Class I
- classification
- November 18, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0212-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0212-2016) was formally reported on November 18, 2015, with the manufacturer initiating the action on October 9, 2015. It is classified under Critical severity (Class I), with a current status of Terminated. Boston Scientific Corporation is listed as the recalling firm, operating out of Maple Grove, MN. Federal records list the affected scope as 955 single units (191 5-packs).
The documented reason for this recall is: Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of c… Distribution data in the federal record shows the product reached: Worldwide Distribution: US Distribution in the states of AZ, CA, DE, FL, GA, IL, LA, MD, MI, MN, NE, NY, PA, SC, TX, WA, and WI, and the countries of Belgium, Germany, Great Britain, Italy, Japan, and South Africa.. 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
955 single units (191 5-packs)
Related Recalls
6
3 from same agency
Product description
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation designed for plaque modification and debulking in vascular interventions. This system is designed to travel over a specialized 0.009 guidewire to guide the path of burr travel to deliver therapy where intended. The guidewires are intended for use with the Rotablator Rotational Atherectomy System.
Reason for recall
Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire fracture.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0212-2016 |
| Date reported | November 18, 2015 |
| Date initiated | October 9, 2015 |
| Recalling firm | Boston Scientific Corporation |
| Firm location | Maple Grove, MN |
| Affected scope | 955 single units (191 5-packs) |
| Distribution | Worldwide Distribution: US Distribution in the states of AZ, CA, DE, FL, GA, IL, LA, MD, MI, MN, NE, NY, PA, SC, TX, WA, and WI, and the countries of Belgium, Germany, Great Britain, Italy, Japan, and South Africa. |
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-0212-2016) 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? ▼
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation designed for plaque modification and debulking in vascular interventions. This system is designed to travel over a specialized 0.009 guidewire to guide the path of burr travel to deliver therapy where intended. The guidewires are intended for use with the Rotablator Rotational Atherectomy System.. Recalled by Boston Scientific Corporation. Units affected: 955 single units (191 5-packs).
Why was this product recalled? ▼
Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire fracture.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 18, 2015. Severity: Critical. Recall number: Z-0212-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US Distribution in the states of AZ, CA, DE, FL, GA, IL, LA, MD, MI, MN, NE, NY, PA, SC, TX, WA, and WI, and the countries of Belgium, Germany, Great Britain, Italy, Japan, and South Africa..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0212-2016) 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 November 18, 2015. 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.