Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported March 20, 2019
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cook Inc. recalled Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transse… - a critical-severity action.
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transse… was recalled by Cook Inc. in March 20, 2019. Reason: The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside …. Check the official notice for the remedy. Verify recall #Z-0979-2019 with the FDA Devices before acting.
The recall
Cook Inc. issued this critical-severity FDA Devices recall-The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside ….
- Critical
- severity level
- 100 units
- affected scope
- Class I
- classification
- March 20, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0979-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0979-2019) was formally reported on March 20, 2019, with the manufacturer initiating the action on February 1, 2019. It is classified under Critical severity (Class I), with a current status of Terminated. Cook Inc. is listed as the recalling firm, operating out of Bloomington, IN. Federal records list the affected scope as 100.
The documented reason for this recall is: The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion. Distribution data in the federal record shows the product reached: US nationwide and Canada. US distribution to the following states: AZ, FL, IL, IN, KS, MA, MI, MO, PA, SC, TN, and WA. The products were distributed to the following foreign countries: Canada.. 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
100
Related Recalls
6
3 from same agency
Product description
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
Reason for recall
The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0979-2019 |
| Date reported | March 20, 2019 |
| Date initiated | February 1, 2019 |
| Recalling firm | Cook Inc. |
| Firm location | Bloomington, IN |
| Affected scope | 100 |
| Distribution | US nationwide and Canada. US distribution to the following states: AZ, FL, IL, IN, KS, MA, MI, MO, PA, SC, TN, and WA. The products were distributed to the following foreign countries: Canada. |
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-0979-2019) 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? ▼
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.. Recalled by Cook Inc.. Units affected: 100.
Why was this product recalled? ▼
The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 20, 2019. Severity: Critical. Recall number: Z-0979-2019.
Where was the recalled product distributed? ▼
Distribution: US nationwide and Canada. US distribution to the following states: AZ, FL, IL, IN, KS, MA, MI, MO, PA, SC, TN, and WA. The products were distributed to the following foreign countries: Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0979-2019) 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 March 20, 2019. 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.