Perouse Medical Recalls Synthes Inflation System Due to Pressure Limitations
Perouse Medical is recalling 2,184 units of the Synthes Inflation System because the device may fail to raise pressure above 10 atm, potentially delaying procedures.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional limitation (inability to raise pressure above 10 atm) that results in incomplete inflation or procedure delay, rather than a direct risk of serious injury or death. This aligns with the 'Moderate' severity criteria for functional defects without reported harm.
Plain-English summary
Perouse Medical is recalling 2,184 units of the Synthes Inflation System (model 03.804.4135). The recall is due to the device's inability to raise pressure above 10 atm during the inflation phase. This limitation may result in incomplete inflation of the balloon catheter or a delay in the procedure.
The affected units were distributed nationwide in the United States, specifically in the states of Arizona and Colorado. The recall involves batch numbers 4041354, 4062650, and 4072586.
The Synthes Inflation System is used during kyphoplasty or other interventional procedures to create and monitor pressure in the balloon catheter and to deflate the catheter. Healthcare providers should stop using the affected units and contact Perouse Medical for instructions on return or replacement.
The recalled product
- Product
- Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to…
- Manufacturer
- PEROUSE MEDICAL
- Affected units
- 2,184
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)
- Batch numbers: 4041354/4062650/4072586
Distribution
Part of a larger recall action
This product is one of 2 recalled by PEROUSE MEDICAL under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · PEROUSE MEDICAL
See all →- ModeratePerouse Medical Recalls Dolphin Inflation Devices Due to Broken Blister
FDA (Devices) · 2017-05-10
- HighBard Caliber Inflation Device Recalled for Pressure Limitations
FDA (Devices) · 2015-01-07
- HighPerouse Flamingo Inflation Devices Recalled for Potential Water-Tightness Defect
FDA (Devices) · 2014-07-30
Same hazard · functional defect
See all →- ModerateSunMed Tracheal Tube Recalled Due to Suction Catheter Passage Issues
FDA (Devices) · 2026-09-23
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
Similar recalls
- HighPerouse Flamingo Inflation Devices Recalled for Potential Water-Tightness Defect
FDA (Devices) · 2014-07-30
- HighMonarch Inflation Device Recalled Due to Sterile Barrier Manufacturing Defect
FDA (Devices) · 2024-10-23
- HighEncore 26 inflation devices recalled over foreign material particles migrating into catheters
FDA (Devices) · 2025-09-17
- HighMedical inflation device recalled due to handle separation risk
FDA (Devices) · 2021-08-04
- HighMonarch Inflation Device Syringe Recalled for Sterile Barrier Defect
FDA (Devices) · 2024-10-23
- HighAngioplasty balloon catheters recalled over inflation and deflation difficulty
FDA (Devices) · 2026-01-21