CLASS II Device recall · Reported 7 Jan 2015 · FDA Enforcement Report
Synthes Inflation System (03.804.4135) recalled by Perouse Medical
Perouse Medical is recalling Synthes Inflation System (03.804.4135), distributed nationwide in the US. The recall was initiated on 6 Oct 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0877-2015
- FDA event ID
- 69879
- Recalling firm
- Perouse Medical, Ivry Le Temple, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Oct 2014
- FDA classified
- 29 Dec 2014
- Reported
- 7 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 6 Oct 2014 | Recall initiated by company | |
| 29 Dec 2014 | Classified by FDA | +84 days |
| 7 Jan 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
Product as listed by the FDA
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 deflate the balloon catheter
Where it was distributed
US Nationwide Distribution in the states of AZ and CO.
Questions about this recall
Why was it recalled?
Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
Which lots are affected?
Batch numbers: 4041354/4062650/4072586
Where was it sold?
US Nationwide Distribution in the states of AZ and CO.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 69879This product is part of a recall event; the main page for the event is Bard Caliber (CL3030) Inflation Device recalled by Perouse Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Bard Caliber (CL3030) Inflation Device recalled by Perouse Medical | Perouse Medical | Other | Nationwide |
More recalls from Perouse Medical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Dolphin Inflation Device Caliber Inflation Device recalled | Perouse Medical | Other | AZ, MN, TN |
| Device | CLASS II | Bard Caliber (CL3030) Inflation Device recalled by Perouse Medical | Perouse Medical | Other | Nationwide |
| Device | CLASS II | Perouse Flamingo recalled by Perouse Medical | Perouse Medical | Other |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |