FDA Adverse Event
Malfunction
Summary report: N
SPATZ3 ADJUSTABLE BALLOON SYSTEM
MDR report key: 24376318
·
Received February 18, 2026
Report
- Report Number
- 3012638928-2026-03491
- Event Type
- Malfunction
- Date Received
- February 18, 2026
- Date of Event
- December 20, 2025
- Report Date
- January 20, 2026
- Manufacturer
- SPATZ FGIA INC.
- Product Code
- LTI
- UDI-DI
- 860005178810
- PMA / PMN Number
- P190012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DEFLATION AND MIGRATION. THE PATIENT CONTACTED US ON 12/19/25 REPORTING BLUE-COLORED URINE. SHE WAS ADVISED TO GO TO HIC SINCE DR. (B)(6) WAS ON VACATION. THE FOLLOWING DAY, SHE WAS SEEN BY DR. (B)(6), WHO REMOVED THE GASTRIC BALLOON VIA ENDOSCOPY; IT WAS COMPLETELY EMPTY AND HAD MIGRATED TO THE PROXIMAL JEJUNUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 437731 | SPATZ3 ADJUSTABLE BALLOON SYSTEM | GASTRIC BALLOON | LTI | SPATZ FGIA INC. | A-SP3-03K | 250210 | 860005178810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female |