Cook Inc. Recalls Formula 418 Renal Balloon-Expandable Stents
Cook Inc. is recalling 10 Formula 418 Renal Balloon-Expandable Stents because the stent may dislodge from the delivery system before deployment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm medical device where injury has not yet been reported, fitting the High severity criteria for theoretical risk without confirmed adverse events.
Plain-English summary
Cook Inc. is recalling 10 units of the Formula 418 Renal Balloon-Expandable Stent, Order Number G56611, Lot 10153876. The recall is due to reports that the stent dislodged from the balloon delivery system prior to deployment.
The affected devices were distributed domestically to Ohio, Iowa, Virginia, and North Carolina, as well as to Canada. The stent is made of 316L stainless steel and is pre-mounted on an over-the-wire balloon catheter.
Use of the affected product may lead to increased procedural time and the need for additional intervention to remove a stent that has dislodged within an unintended location. No injuries or illnesses have been reported in the source text.
The recalled product
- Product
- Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system.…
- Manufacturer
- Cook Inc.
- Affected units
- 10
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 number 10153876
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 Needle with Catheter Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
- HighTransseptal Needles Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- SevereCook Medical Kwart Retro-Inject Ureteral Stent Set Recalled for Material Defect
FDA (Devices) · 2021-02-17
- HighCook Inc. Recalls Bander Ureteral Diversion Open-End Stent Sets
FDA (Devices) · 2020-02-12
- ModerateCook Kwart Retro-Inject Ureteral Stent Set Recalled for Missing Warning
FDA (Devices) · 2019-05-29
- ModerateBard Fluoro-4 Silicone Ureteral Stent Recall for Labeling Update
FDA (Devices) · 2016-11-23
- CriticalCook Inc. Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheters
FDA (Devices) · 2019-06-26
- SevereCook Inc. Recalls Sof-Flex Ureteral Stent Sets Due to Loading Error
FDA (Devices) · 2020-02-12