FDA Devices recall · Reported January 7, 2015
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
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
Perouse Medical recalled Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used durin… - a moderate-severity action.
Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used durin… was recalled by Perouse Medical in January 7, 2015. Reason: Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase ma…. Check the official notice for the remedy. Verify recall #Z-0877-2015 with the FDA Devices before acting.
The recall
Perouse Medical issued this moderate-severity FDA Devices recall-Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase ma….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- January 7, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0877-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0877-2015) was formally reported on January 7, 2015, with the manufacturer initiating the action on October 6, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Perouse Medical is listed as the recalling firm, operating out of Ivry Le Temple, N/A. Federal records list the affected scope as 2184 units.
The documented reason for this recall is: 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 Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of AZ and CO.. 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, 6 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0877-2015 |
| Date reported | January 7, 2015 |
| Date initiated | October 6, 2014 |
| Recalling firm | Perouse Medical |
| Firm location | Ivry Le Temple, N/A |
| Affected scope | 2184 units |
| Distribution | US Nationwide Distribution in the states of AZ and CO. |
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-0877-2015) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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.
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Similar severity · nearest report date
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Methodology · Corrections · Archive as of August 2026