Food, drugs, devices › Boston Scientific Corporation
Device recall: Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open su
FDA enforcement event 79608 is a device recall by Boston Scientific Corporation of Marlborough, MA, initiated 12 Feb 2018 and classified Class II, with 11 product records.
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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 10 Apr 2020. Initiation: voluntary: firm initiated. Boston Scientific Corporation has 162 enforcement events on this register, with a median of 2 product records 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
Boston Scientific Corporation, Marlborough, MA.
Reason for recall
"Potential for Capio sutures to break and /or detach."
Distribution
"Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1616-2018 | Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site. | 21,250 | Class II | Terminated | 16 May 2018 |
| Z-1617-2018 | Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site. | 60,538 | Class II | Terminated | 16 May 2018 |
| Z-1618-2018 | Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures. | 1,258 | Class II | Terminated | 16 May 2018 |
| Z-1619-2018 | Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site. | 21,051 | Class II | Terminated | 16 May 2018 |
| Z-1620-2018 | Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site. | 4,144 | Class II | Terminated | 16 May 2018 |
| Z-1621-2018 | Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site. | 2,567 | Class II | Terminated | 16 May 2018 |
| Z-1622-2018 | Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse. | 24,126 | Class II | Terminated | 16 May 2018 |
| Z-1623-2018 | Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse. | 1,541 | Class II | Terminated | 16 May 2018 |
| Z-1624-2018 | PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse. | 34 | Class II | Terminated | 16 May 2018 |
| Z-1625-2018 | PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse. | 24 | Class II | Terminated | 16 May 2018 |
| Z-1626-2018 | Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in women with pelvic organ prolapse. | 1,002 | Class II | Terminated | 16 May 2018 |
Context
Other enforcement events for Boston Scientific Corporation
All 162 events for Boston Scientific Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential for Capio sutures to break and /or detach."
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: "Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Apr 2020. "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.