Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported July 29, 2026
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orien…
Boston Scientific Corporation recalled FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into t… - a moderate-severity action.
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into t… was recalled by Boston Scientific Corporation in July 29, 2026. Reason: Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are asso…. Check the official notice for the remedy. Verify recall #Z-2755-2026 with the FDA Devices before acting.
The recall
Boston Scientific Corporation issued this moderate-severity FDA Devices recall-Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are asso….
- Moderate
- severity level
- 75K units
- affected scope
- Class II
- classification
- July 29, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2755-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2755-2026) was formally reported on July 29, 2026, with the manufacturer initiating the action on June 11, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Boston Scientific Corporation is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 74,760 units.
The documented reason for this recall is: Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve … Distribution data in the federal record shows the product reached: Global Distribution. US Nationwide.. 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, 6 from FDA Devices and 2 from Boston Scientific Corporation - 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
74,760 units
Related Recalls
6
6 from same agency
Product description
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
Reason for recall
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2755-2026 |
| Date reported | July 29, 2026 |
| Date initiated | June 11, 2026 |
| Recalling firm | Boston Scientific Corporation |
| Firm location | Saint Paul, MN |
| Affected scope | 74,760 units |
| Distribution | Global Distribution. US Nationwide. |
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-2755-2026) 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? ▼
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062. Recalled by Boston Scientific Corporation. Units affected: 74,760 units.
Why was this product recalled? ▼
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 29, 2026. Severity: Moderate. Recall number: Z-2755-2026.
Where was the recalled product distributed? ▼
Distribution: Global Distribution. US Nationwide..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2755-2026) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
FDA Devices Moderate
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cathe…
Boston Scientific Corporation · 2026-07-29
FDA Devices Moderate
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
AVID Medical, Inc. · 2026-07-29
FDA Devices Moderate
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Penumbra, Inc. · 2026-07-29
FDA Devices Moderate
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Alphatec Spine, Inc. · 2026-07-29
FDA Devices Moderate
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Medtronic MiniMed, Inc. · 2026-07-29
Compare this recall with FARASTAR Ablation Generator EU, Pulsed Field Ablation Gener… →
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 July 29, 2026. 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 August 2026.