Cook Transseptal Needle Recalled for Missing Back Bevel
Cook Inc. is recalling 100 units of Transseptal Needles manufactured without a back bevel on the needle tip, which could damage the introducer during insertion.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."
Plain-English summary
Cook Inc. is recalling 100 units of the Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364, Lot 8833687. These medical devices are used for transseptal left heart access in both diagnostic and interventional procedures.
The recall was initiated because the products were manufactured without a back bevel on the needle tip. According to the source, this defect could cause damage to the inside of the introducer during needle insertion.
The affected products were distributed nationwide in the United States and in Canada. In the US, distribution was limited to Arizona, Florida, Illinois, Indiana, Kansas, Massachusetts, Michigan, Missouri, Pennsylvania, South Carolina, Tennessee, and Washington. Consumers and healthcare providers should stop using the affected needles and contact Cook Inc. for further instructions.
The recalled product
- Product
- Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 8833687
Distribution
Related recalls
Same manufacturer · Cook Inc.
See all →- HighSkinny Needle with Chiba Tip recalled for debris contamination
FDA (Devices) · 2021-12-29
- HighCook Flexor Check-Flo Introducer recalled for size mislabeling
FDA (Devices) · 2021-12-22
- ModerateFlexor Check-Flo Introducer Recalled for Mislabeled Caliber Size
FDA (Devices) · 2021-12-22
- HighTransseptal Needles Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
- HighTransseptal Needle with Catheter Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
Same hazard · equipment damage
See all →- HighOlympus Cystoscope Outer Sheath Recalled Due to Potential Device Tip Damage
FDA (Devices) · 2026-03-04
- ModerateIncisive CT systems recalled because tube heat exchanger screws may not be tightened
FDA (Devices) · 2025-12-10
- ModerateCT scanners recalled because tube heat exchanger screws may not be tightened
FDA (Devices) · 2025-12-10
- HighPower Express PE Centrifuge adhesive joint failure may cause component detachment
FDA (Devices) · 2024-09-11
- HighBeckman Coulter DxI 9000 Analyzer Recalled for Leaking Wash Buffer Tank
FDA (Devices) · 2024-09-11
Similar recalls
- HighTransseptal Needles Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
- HighTransseptal Needle with Catheter Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
- HighCook Inc. Recalls Bander Ureteral Diversion Open-End Stent Sets
FDA (Devices) · 2020-02-12
- SevereHeartspan Transseptal Needle Recall Due to Tip Curvature Mismatch
FDA (Devices) · 2021-03-24
- HighCook Inc. Recalls Kopans Breast Lesion Localization Needles
FDA (Devices) · 2016-03-09
- SevereMerit Medical Recalls HeartSpan Transseptal Needles Due to Tip Curvature Mismatch
FDA (Devices) · 2021-03-24