Food, drugs, devices › Maquet Cardiovascular Us Sales, Llc
Device recall: The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests
FDA enforcement event 74915 is a device recall by Maquet Cardiovascular Us Sales, Llc of Wayne, NJ, initiated 12 Aug 2016 and classified Class II, with 1 product record.
FDA defines Class II as 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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 4 May 2017. Initiation: voluntary: firm initiated. Maquet Cardiovascular Us Sales, Llc has 40 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Maquet Cardiovascular Us Sales, Llc, Wayne, NJ.
Reason for recall
"Post Market Surveillance cases reported to Maquet showing instances in which the welded joint between the square mount and the first fixable swivel joint of Maquet's Connecting Bracket (Fixture) Device is broken."
Distribution
"Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2746-2016 | The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical interventions as well as for examination and treatment. The fixture is used to adapt a range of different head and… | 19 units (US) and 1975 units (OUS) | Class II | Terminated | 14 Sep 2016 |
Context
Other enforcement events for Maquet Cardiovascular Us Sales, Llc
All 40 events for Maquet Cardiovascular Us Sales, Llc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Post Market Surveillance cases reported to Maquet showing instances in which the welded joint between the square mount and the first fixable swivel joint of Maquet's Connecting Bracket (Fixture) Device is broken."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 May 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.