Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 31, 2012
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi
We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. We became aware of these interactions while investigati…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Greatbatch Medical recalled Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010… - a moderate-severity action.
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010… was recalled by Greatbatch Medical in October 31, 2012. Reason: We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Gui…. Check the official notice for the remedy. Verify recall #Z-0132-2013 with the FDA Devices before acting.
The recall
Greatbatch Medical issued this moderate-severity FDA Devices recall-We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Gui….
- Moderate
- severity level
- 9K units
- affected scope
- Class II
- classification
- October 31, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0132-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0132-2013) was formally reported on October 31, 2012, with the manufacturer initiating the action on September 24, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Greatbatch Medical is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 9040.
The documented reason for this recall is: We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. We became aware of these interactions while investigating recent complaints regarding catheters… Distribution data in the federal record shows the product reached: Nationwide distribution: CA only.. 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
9040
Related Recalls
6
3 from same agency
Product description
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart. Including the left side of the heart through the interatrial septum.
Reason for recall
We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. We became aware of these interactions while investigating recent complaints regarding catheters "self-advancing" while being used in conjunction with the MobiCath Sheaths.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0132-2013 |
| Date reported | October 31, 2012 |
| Date initiated | September 24, 2012 |
| Recalling firm | Greatbatch Medical |
| Firm location | Minneapolis, MN |
| Affected scope | 9040 |
| Distribution | Nationwide distribution: CA only. |
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-0132-2013) 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? ▼
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart. Including the left side of the heart through the interatrial septum.. Recalled by Greatbatch Medical. Units affected: 9040.
Why was this product recalled? ▼
We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. We became aware of these interactions while investigating recent complaints regarding catheters "self-advancing" while being used in conjunction with the MobiCath Sheaths.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 31, 2012. Severity: Moderate. Recall number: Z-0132-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution: CA only..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0132-2013) 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 October 31, 2012. 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.